FDA Suddenly Bans Drugs That Have Been On The Market For Decades

from the perfect-gin-and-tonic-for-fun-and-profit dept

As Techdirt recently discussed, the drug pipeline is running
dry, as Big Pharma's patents are beginning to expire, and the drug companies are freaking out. For years they have been spending more money on research and testing and getting fewer results. This year alone they are
going to have 11 patents expire on drugs that bring in approximately $50 billion in revenue to the big pharma firms. Of course, the flip side to this is that consumers can start saving about 95% on the price of those drugs, as generics hit the market. The
drug companies have gotten to a point where the incremental increases in
efficiencies are so small as to be meaningless. What is coming is more personalized and targeted treatments for diseases -- treatments that do not
require bulk production of a specific chemical, but individual testing and
personalized care, and not lifetime treatments and repeat sales, but cures. The treatments will be expensive to begin with, but they will become less expensive over
time. The business model of healthcare is about to
change dramatically, and Big Pharma needs to do something to maintain their profits.
Unfortunately, they seem to have chosen the path of regulating the competition
out of existence, rather than competing and innovating.

One way the drug companies have been coping is to repackage and rebrand
health food supplements. Drugs like Lovaza, which is nothing
more than the fish oil you can get in health food stores, and
lovastatin which has been in use for roughly a thousand years
(800 AD) in the form of red yeast rice. In the case of
lovastatin, the FDA banned the supplements because they are "identical to a drug
and, thus, subject to regulation as a drug." That is very convenient
for the drug company, which now charges monopoly rents on the product -- which can increase prices at ridiculous levels.

More recently, the FDA banned 500 prescription drugs that had been on the market and working for years. To be fair, it was really 50-100 drugs (pdf), made by different companies, but that just highlights how there was actual competition in the marketplace for these drugs, which has now been removed. For
all of the drugs, there is either a high-priced prescription version, or all
the small manufacturers have been removed, leaving a virtual monopoly for one
or more larger companies. This process began in 2006 when the
FDA decided to remove marketed unapproved drugs (pdf).

The reasoning is that these drugs weren't ever technically "approved" by the FDA. While the FDA has been around for about a century, the business of having the FDA first approve drugs before they could go on the market came about closer to fifty years ago, and a bunch of "unapproved drugs" that were in common usage before that never got approved. The FDA is targeting many of those, even if they have a long history in the marketplace. Conveniently, of course, there always seems to be a pharma company with a monopolized substitute ready.

Another drug removed was the antihistamine carbinoxamine,
which was created prior to needing FDA approval, in the early 1950s. It was
approved by the FDA in a slightly modified form in 2006. It is
now sold exclusively by Mikart, Inc and Pamlab, LLC with no future competition
because the FDA has banned all 120 other
versions of carbinoxamine. You can imagine just how much that must increase the profits for Mikart and Pamlab on carbinoxamine, though that seems to come at the expense of consumers.

It's
really nice being granted a government monopoly.

As for the drugs now being banned in this latest purge, you can argue that it's not really 500
drugs, because many are different combinations of the same 50 to 100 drugs.
To be sold, these disapproved drugs will require drug trials and
certification -- a massive and expensive process. Under current law, after
successful completion of FDA trials these drugs will be granted approval. But
in every case these trials are almost certainly not necessary. And, "coincidentally" in almost every case, there is a chemically similar
patented version ready to go. This is a pure money grab: replacing old
tried and true drugs, with monopoly priced prescription drugs. It just
requires removing competing drugs from the market to increase profits.

And with that, I'm off to go have a gin and tonic, while it's still legal...

The government says there's a problem:
(high health care costs)
The government proceeds to act in ways that aggravate the problem:
(Increase the cost of drugs by destroying competition)
Sounds about par for the course.

Unless they can prove these competitors were making drugs that were harmful or unsafe, it's likely some form of veiled cronyism or misguided incompetence.

I eagerly await for the next mistake along this continuum:
(Government institutes price controls)

The American Way

All you bleeding hearts, come on!

Its the American way, we need to preserve profits because thats the only way the Great Pharma companies will fund leading research. What do you think, we will get it from China too? No Way Hose! Not even across the border.

Look on average, drug companies mark up their prescription drugs as much as 569,000% over the price of the raw materials (A typical markup is more in the 30,000% - 50,000% range.)
I think if we can sustain a margin around this ball park range, the future of medical research will be in safe hands, namely mine. Crazy ideas conjured up by anti American communist senators like Dorgan Gorgan or whatever that snake charmer calls himself, should be sent back to the Greeks with their myths.

Re: The American Way

"Look on average, drug companies mark up their prescription drugs as much as 569,000% over the price of the raw materials (A typical markup is more in the 30,000% - 50,000% range.)"

[Citation Needed] for the markups.

This is about the removal of generic drugs from the market. Its about replacing them with "FDA approved" drugs, that come with monopoly prices attached. It is about removing competition from the market place. Misdirecting the conversation to the "high" (snicker) cost of new drugs is just laughable. Generic and non-generic drugs are apples and oranges.

Re: Re: The American Way

Well, how about this. The active ingredient in my phosphorous binder (dialysis patients have to use these to control the amount of phosphorous in their system) is the same ingredient as in Tums. How much is a 100 count bottle of Tums? My prescription binder costs $870 for 200. A one month supply.

Wow, just wow...

It is really hard to imagine that lawmakers, lobbyists and corporate execs can really put peoples lives and finances at risk just to line their own pockets.

It is one thing to charge absurd prices for luxury items that people don't need and buy voluntarily. It is quite another to do this when people's health and even their lives are at risk. They better hope there is no hell because if there is, and I believe there is, there will probably be a special place for them.

The FDA isn't a government agency.

It's now another corporation, since those who run the FDA are former employees of those very companies who benefit from monopolies.

It's pretty bad when these corporations have infiltrated every office of government, from SCOTUS (which granted patent rights on nature), to the Dept of Justice (Hello, Neo RIAA), to offices like the FDA, now in the business of killing people rather than saving them.

I still have faith people will eventually wake up and make changes to government to fix it, but every year, and with every new law passed/introduced, such as the HCRA and COICA, I lose a piece that faith, especially when those very politicians use the very words as given to them by those who supplied their campaign contributions with more money than most of us will earn in our lifetime.

Re: The FDA isn't a government agency.

So true. They don't care bout those of us who are actually In serious pain. Simply put, (and I hate to say it) but all they care about is makin a few extra bucks at the cost of the American ppl who are responsible enough to use these prescriptions responsibly. Shame on them and the way our economic system Wrks today in our society.

Finally, treating supplements which alter your body chemistry as drugs, since there is no fundamental difference. Who knows, maybe we'll start to condemn the wild west that is the supplement industry(which is mostly bunk, where they can claim what they want without retribution, proof or even telling you what concentration they sell) if we could get around some of crappy legislation that is out there.

I can't wait for the time when the FDA requires the dose curves(i.e. showing that the drugs are the same as what's out there) to match what was originally filed before they allow the generics to come on the market, then we'll get the cry that Big Pharma is killing the generic industry by forcing them to show efficacy and safety for a product that acts differently.

You have a trade off with the FDA, we can either allow anyone in the market for little price and force regular people to decide which drugs work, or force companies to prove to the FDA that changing your body's chemistry is safe and efficacious.

Re: Re: And!

Lobo,
If I link you too 1500 articles which all claim to fix the same problem, would you have the time(or know how) to decide what is best for you? Or even if any of those drugs are more than snake oil? Hell, even now we have scumbags who sell bracelets with a refrigerator magnet claiming they improve balance, health, etc. and people buy them up thinking they work. In the wild "west" all I'd have to do is put (2R,3S,4R,5R)-2,3,5,4,6-Pentahydroxyhexana and dihydrogen monoxide on the label and people's eyes would glaze over(my product is sugar water, for those non-chemistry people). It's safe, it works(as a placebo), and ultimately nobody would know differently.

In your wild west we would degrade to selling products which are entirely safe, and could be marketed the best, not which compounds are shown to be safe and shown to work through scientific study. Sure, things cost more, but in this scenario we incrementally increase health, where your scenario we just spin our wheels with false advertising.

Re: Re: Re: And!

Now, imagine competing private quality assurance corporations who say things like "this drug is just sugar water!" and who must earn the fickle publics' trust over time... Their business model involves having a pristine reputation and accepting fees from companies which wish to have their products tested and certified by said company(ies).

To put it another way: there is a little truth in your fiction and a little fiction in your truth.

Snake Oil, by the way, has a bad reputation due to a propaganda campaign from Bayer (if I recall correctly) not because of any harmful effects of inefficacy.

Re: Re: Re: Re: And!

So your solution is to privatize it and hope that private companies won't fall into the same mold as you believe the FDA is in(I'm not really sure that it's filled with all the evilness that some on this site think). Really, we're trading one thing for the other.

Snake oil actually has some use, but I don't believe it's for anything that it was actually marketed to cure. All I ask is that if you're making claims that what you sell(drug or "supplement") is somewhat verified by a 3rd party and it won't harm(or at least the harms are fully disclosed so those prescribing the medicines can use their best judgment).

To me, the story isn't taking these drugs off the market, it was originally allowing these supplements on the market. Let's give a hypo to show why I thought it was a problem: Supplement x contains aspirin, consumer buys it to cure his headache, since there is no concentration on the package(or instructions on how to take it) consumer takes too much an overdoses. The other problem is that with any supplement, the active ingredient is variable, so it's tough to actually use it to treat with the specificity that you want.

Re: Re: Re: Re: Re: And!

So your solution is to privatize it

Yes. Third party companies would pop up to sign-off on (and possibly underwrite) drugs. If they screw up, they not only lose money in lawsuits, but also lose consumer confidence. If consumers don't trust that the validating company is testing the drugs properly, their label on the front of the bottle won't be of any value to the drug companies, who will go with someone else.

Re: Re: Re: Re: Re: Re: And!

Really, you're trading 6 for a half dozen(if that). You act like if there was a big business of certified trademarkers stamping drugs as CWFP approved, with a huge lobby group in DC, there would really be any difference? These companies would find ways to underfund themselves so they wouldn't have to pay out if they made mistakes, or even pass blame like the gulf oil spill and make litigation so monumentally cumbersome that it wouldn't be worth it. Call it cynicism in free market economics, but nothing has shown me that completely open commerce can restrain itself or that the threat of private litigation would cause a company to act ethically.

Either way, 10 years from now you'd have the same gripes, that industry has infiltrated XYZ, it's no good, big pharma does what they want, and nobody will buy something unless it's approved by xyz so small companies still need to jump through the hoops and pay big fees to get onto the market.

Re: Re: Re: And!

End the hypothetical posturing.

Most of the drugs on the list have been in use for decades; if there were any safety concerns I'm sure they would have come to light by now.

As for efficacy, perhaps you should read up on the pharmaceutical industry. Most drugs have inconsistent results and only a very small number of drugs could pass a test which compared their outcome to that of a placebo.

Re: Re: Re: Re: And!

My concerns aren't necessarily whether the low levels in the supplements will harm you, I'm sure they won't. My concerns are that concentrations can very, and interactions could dramatically change from dose to dose. I also think that a secondary effect is that it will bring to light that these things are actually drugs, so people will disclose them to doctors when they are ill, so Drs can make sure that other drugs won't interact with the supplement.

I have my own griefs with what the pharmaceutical industry does, and honestly think that most companies should be fined out the yin-yang(double profits?) for lying about a drug to the FDA. I don't necessarily think that means most drugs have inconsistent results, or that in the right hands the studies can't be put into the proper context(I've heard clinicians say that you take pharma studies and subtract 20% from efficacy to decide whether you want to use it or not).

Re: Re: Re: And!

CarlWeathersForPres,

The solution is multi fold. Allow any drugs that are no longer patented to become generic. Prevent the FDA from removing generic drugs from the market unless they possess some health risk. Allow anyone to produce generic drugs as long as they undergo USP standards testing every n months and on a random basis.

Re: Re: Re: Re: And!

These weren't generic drugs, they banned supplements because they contained pharmaceutical compounds and were supposed to be regulated under the FDA. If you're selling a generic, you still have to file with the FDA(and you piggy back off the studies by big pharma), you can't just put controlled substances in what you want because it's generic.

Re: Re: Re: Re: Re: Re: And!

You're telling me that the link that David has to a forum post wasn't what he was going off about in his thesis paragraph(removal of supplements because they have drug counterparts)? All the other links are somewhat suspect and just say drugs have been removed, and don't really specify a reason(which I'm not jumping on the conspiracy train because they banned "A TAN 12X SUSPENSION" for not filing the proper paperwork to show its legit). What is wrong with removing drugs from the market which have not been approved?

Re: Re: Re: Re: Re: Re: Re: And!

Re: Re: Re: And!

"In your wild west we would degrade to selling products which are entirely safe, and could be marketed the best, not which compounds are shown to be safe and shown to work through scientific study."

The point of this article today is that most of the FDA action is NOT a case of "taming the wild west".
Many of the drugs which the FDA have removed had no history of problems after having been marketed for decades. Now if you are suspicious, you can believe that maybe connections between regulators and industry provoked these actions, but more likely its a matter of bureaucrats being bureaucrats and wanting to make manufacturers meet current standards, rather than the standards which were in place when the drugs first came to market.

A few days ago the drug Delalutin = Makena was discussed on Techdirt, and I laid out what had gone wrong with the market in that situation. The sky-high prices with Makena didn't come about because of patents. The issue is exactly what is being discussed in this post --> Regulatory activity delivering a Monopoly to a manufacturer. Since I posted so late on that article, it missed the reading cycle so if you didn't see it, the explanation of what happened with Makena can be read here.

Re: Re: Re: Re: And!

Re: Re: Re: Re: Re: And!

"Why was Delalutin's FDA approval withdrawn?"

To get the exact answer to that, you would have to ask someone who was in management of Bristol Meyers Squibb in 1999.
However, what is known, is that BMS asked the FDA to rescind approval for the drug.
A reasonable guess would be that since BMS had decided that they would no longer market it [ probably because of lawsuits + low market volume], that they wanted to impair any other company from using the approval Squibb had obtained years before to bring it back to market. Perhaps this was a bit of preemptive restraint of the generic manufacturing companies who the "big-pharma" corporations have frequently sparred with over the years.
You can read more about it Here.

Re: Re: Re: Re: Re: Re: And!

The most relevant passage:
"ANDAs that refer to DELALUTIN (hydroxyprogesterone caproate) injection, 125 mg/mL and 250 mg/mL, may be approved by the agency as long as they meet all relevant legal and regulatory requirements for approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling." Essentially, from reading your linked article, they filed paperwork saying they no longer made the drug(which is probably required by law).

An ANDA is the document you file(which costs relatively little) which makes it so you can use the safety and efficacy data from the original filing(which BMS did). You linked me to a document saying that anyone could make the drug as long as they followed the rules they normally had to follow.

I don't understand the outcry from doing what you're supposed to do by law and then allowing someone to manufacture a drug by filing some paperwork which makes it so they don't have to proceed with a myriad of tests and pay smaller filing fees.

Re: Re: Re: Re: Re: Re: Re: And!

"I don't understand the outcry from doing what you're supposed to do by law and then allowing someone to manufacture a drug by filing some paperwork which makes it so they don't have to proceed with a myriad of tests and pay smaller filing fees."

There's nothing wrong at all with ANDAs. They are a good thing.

The outcry is all about government regulators gift-wrapping and delivering a monopoly to a single company.

Read my comment in the other post about Makena this week that explains how this happens.
Plain and simple, Monopolies are BAD. Normal market forces don't have the opportunity to work.

If you want to play the "safety card" and say the FDA is just protecting us from unsafe drugs, I argue 2 points in return:
1) These were old drugs with a track-record lasting decades. Little or no evidence of danger had arisen in that period
2) Monopoly is itself a safety issue, because if you can't afford a treatment like Makena that now costs $30,000, then your unborn child dies.

Re: Re: Re: Re: Re: Re: Re: Re: And!

This isn't a monopoly issue, when the companies wanted to bring the drug back to market they filed an ANDA and that was it. How do you not understand that BMS was saying that they no longer sold that specific pharmaceutical, therefore it went into the list of drugs that were approved but no longer sold, and then when whichever company wanted to manufacture it again they just filed an ANDA and when it was processed they were allowed? You're giving me links that say the opposite of what you're claiming, and when I read them and explain them you bring up the same red herrings and misinformation and tell me to read something else.

Re: Re: Re: Re: Re: Re: Re: Re: Re: And!

Carl:

KV Pharmaceutical is the only company currently allowed to produce and market hydroxyprogesterone for the treatment of halting premature labor. That is a monopoly.
No the FDA is not preventing anyone else from ending KV Pharmaceutical's monopoly by filing their own ANDA, but KV Pharmaceutical wouldn't have the monopoly at all were it not for FDA regulatory activity.

Let me try again to explain to you how this happened.

The FDA certainly did withdraw approval for the distribution of hydroxyprogesterone in 2000.
In 2006, the FDA issued a determination that the withdrawal had been for non-safety reasons, and that therefore they would allow an ANDA.

In the period since that time, the FDA has forced compounding pharmacies from the market for this drug. Compounding pharmacies generally rarely advertise their services to physicians, and definitely not to patients. They produce the compounds on a case by case basis at the request of physician. Nonetheless that is sufficient to provide an alternative source if the price of a drug is deemed exorbitant.It is the FDA's act of preventing the compounding pharmacies from selling hydroxyprogesterone that allows the KV Pharmaceutical to enjoy monopoly market leverage needed to charge $30,000 for a treatment regimen.

Sure anyone else can submit an ANDA for this drug, because KV Pharmaceutical doesn't have a patent, but that doesn't mean there isn't a regulatory monopoly at this moment. You seem to be equating monopoly with patent protection. I am telling you there are other paths to monopoly.

You should realize that filing an ANDA isn't necessarily a trivial endeavor which will be automatically be approved in a very short time. Testing and verification of results is still required and then paperwork must still be presented and committees must review it.
Observe that it took 5 years from the time that the FDA issued its determination that it would allow an ANDA until the first ANDA was approved this year.
At this point, there is no telling how long it will be till the next one is approved, but until it does there is no competition for KV Pharmaceutical.
That is the definition of a monopoly

Re: Re:

They are doing this..

cause the drug companies are slipping them money under the table. Most government agencies either get money from the groups they are supposed to regulate or the groups slip the money to Congressmen who then apply pressure on the agencies. In most countries this would be considered bribery, but here it's just business as usual.

The big pharma companies and the health care insurance people are the biggest obstacles to affordable health care for all in the U.S..

Hi

They did this with urokinase a few years ago. The new alternative tPA was too expensive compared to urokinase. Since urokinase was made from cultures of uroepithelial cells, someone suggested there might be a infection risk, although no had been reported in the 40 million administered doses.

Money literally is the root of all evil.

It's really getting to the point where having to give the same answer to every problem is getting to feel kind of repetitive, but the problem as always is our societal system, specifically it being based on money and profit. We have to transcend the primitive barter systems that are currently destroying the world and mankind (quite literally) and move on to some actual civilization - like a resource-based economy. That will solve a huge amount of our current woes, like this one. Perfection? Not even close... but certainly vastly better than our current mess.

Please don't tell Mike that is actually costs money to develop drugs, or that big pharma companies are actually spending money to develop new drugs, or that it is getting harder and harder to develop them. That would ruin him.

EVIL

it's just amazing to me how much our government is corrupt and how much money changes hands via lobbyists so that this $hit happens. I agree with another post. I believe there is a hell and they will all be there together...with no perscriptions to fight off the eternal pain and suffering.

Can we use this to point to political hypocrisy?

I'm guessing that some of the corporate execs hoping to benefit from this have also supported a decrease in government regulations that get in their way.

I've found very few people who actually want less government. All they are really debating is what government gets to regulate. As long as the laws help them, they like the laws. Whenever the laws cost them money, then they don't like them.

I love these drug companies. I have high blood pressure and finally found a drug that works, Azor. Daiichi Sankyo a Japanese company makes Azor and has a patent until 2016. Prices have probably come down now but 2 years ago they were selling it for over $400 for a 30 day supply. What is Azor? A combination of two generically available high blood pressure medications that combined cost a total of $35 a month (that's the no insurance total cost of them). But by putting both of them into 1 pill they get granted a patent that lasts another 5 years in the US. The drug companies don't give a crap about making people better just how much profit they can make.

Re:

DCA: A CHEAP cancer treatment the FDA process has majorly affected

I read about a discovery in 2007 where 70-something percent of cancer in rats was cured by a simple drug we didn't know had an effect on cancer until some scientist/doctor happened to test it. I was excited because I knew with something that big, it would be brought to patients as fast as possible.

Well, I stumbled upon it again while debunking and fact-checking all the stupid "cures" and old wive's tales on cancer....in 2010! They literally had JUST started getting enough support to pay for the stupidly expensive and unnecessary trials 3 years later! The reason?

Dichloroacetate (DCA) is a simple compound(not a drug) and can't be patented in it's natural form. Nobody wanted to spend however many millions(billions?) on trials if they can't make that investment back somehow. Plus, it would be a bad business decision to help bring a cancer "cure" to the market when they make so much off of high-priced ineffective "treatments" that sometimes cure, but mostly just extend life. The longer you extend by using their drug regularly, the longer they make money. Simple math and good business sense really...

If it is relatively inexpensive and no one wants to patent it, couldn't there be a cottage industry making and providing it? If no one wants to fund the research, there wouldn't be scientific proof that it works, but if it does no harm and does work, then people could self-medicate or go to practitioners who obtain a supply and experiment with it.

When a drug company sent government workers in the FDA microwave ovens as a "gift" several years ago and the FDA didn't tell the workers to return them I figured the FDA was bound corruption's way.
If you want things to change you need to get together in large lobbying groups and force your corrupted government to reform. And if you don't then you will be living in a country as corrupt as any you could name, very shortly.

needs clarification

The article brings up good questions but it glosses over many issues that need to be looked at in more detail. I will just deal with Lovastatin.
I see the FDA as serving a useful function in the case when it bans the sale of red yeast rice for use as a medicine when a drug (lovastatin) is made and tested that is also found in the red yeast rice. The most important aspect of this is that the dosage is known and controlled in the manufactured drug. This makes it more effective and safer to use. One caveat, there might be multiple compounds in the red yeast rice that would make it more effective than Lovastatin alone. This may not be true with Lovastatin but can be true with other naturally occurring medicines.
My understanding is that if a drug is derived from a plant (i.e. naturally occurring) it cannot be patented. I have not researched this thoroughly so the next discussion is part guesswork. However, it is something that should have been brought up in the article.
The first question is, how did Merck get a patent on something that occurred naturally? It looks like the FDA's attempt to ban the medicinal use of red yeast rice in 1997 was overturned by the courts because you cannot patent something that is naturally occurring. The patent expired in 2001. So, Lovastatin can now be manufactured generically. Any attempts now by the FDA to ban the medicinal use of red yeast rice can be based simply on the Lovastatin being more effective and safer. I think it's a good idea to let the FDA ban medicinal use of supplements that contain approved drugs. However, since supplements are usually derived from naturally occurring substances, a company should not have exclusive rights to make that drug.

Re: needs clarification

"Any attempts now by the FDA to ban the medicinal use of red yeast rice can be based simply on the Lovastatin being more effective and safer."

The evidence/studies on the matter support the opposite.

Lets just ban pure water because it cures dehydration and is hence a drug and companies sell alternative ways to hydrate us, like Gatorade, and they're safer and more effective. Not enough studies on the benefits of water. Maybe we need FDA approval for Gatorade and for water because they're being used as drugs to cure dehydration.

What about apples, they have vitamin C, but who cares, we need more studies on it, and there aren't enough FDA approved clinical trials. After all, apples are good for you, they provide a health benefit, along with most other foods, and those health benefits are medicinal in nature and can perhaps also be provided more safely and effectively with FDA approved pharmaceutical drugs. Food cures starvation, it's a drug, so lets just ban foods and replace them all with FDA approved drugs.

The FDA banned red yeast rice for absolutely no good reason (or at least red yeast rice naturally containing more than just trace amounts of lovastatin), no different than banning apples and bananas for any health benefits they provide. All the studies on it showed that it was safer and more effective than pharmaceutical alternatives. Cholesterol lowering Phara drugs have been responsible for killing hundreds of people before being taken off the market (ie: Bayers drug Baycol), red yeast rice hasn't been responsible for a single death. From what I remember, it was a pharmaceutical corporation that initially petitioned them to ban it because it competed with what they sold, and that's when they started their vendetta against it, though no recent articles on the matter seem to indicate so.

Red yeast rice is actually shown to save lives. If the government really cared about safety, they would ban cigarettes, which has killed far more people (in opposed to zero), but health freedom is perfectly OK so long as it helps big corporations. When it harms them, it's not acceptable.

Re: needs clarification

"I see the FDA as serving a useful function in the case when it bans the sale of red yeast rice for use as a medicine when a drug (lovastatin) is made and tested that is also found in the red yeast rice. The most important aspect of this is that the dosage is known and controlled in the manufactured drug. This makes it more effective and safer to use."

What's the appropriate dose of apples before too many are bad for you? How many should you take so that they cure various vitamin deficiencies yet don't harm you.

If I want to take substance X for problem Y, that's MY business. No one is forcing you to take it. You don't want to take red yeast rice because of xyz reasons, that's your business, I can't force you to do it. But you have absolutely NO right to tell me what I can and can't take or sell. I am in a better position to determine what's in my best interest than you or even the FDA. Sure, it could harm me, but again, that's my business, it's no one elses business and the FDA needs to mind its own business.

They do have an important job though, to make sure that everything that's in the bottle is on the label and to make sure that everything that's on the label is in the bottle so that I know exactly what I'm buying. Other than that, mind your own business, let me worry about my own safety and let me weigh the pros, cons, and risks of what I take.

Guaifenesin, another example

Again, I have not researched this exhaustively. If someone else has more detail, I would like to hear it.
Guaifenesin is one of the drugs that has been around awhile. The FDA is banning all time-release formulations of Guaifensin. The rationale is that these drugs are competing against an approved drug. The issue is really about formulations. The newly approved drug is extended-release which has shown to be more effective and safer than the time-release formulations and there is a patent on the formulation, not the drug itself. I don't think that the FDA is banning all the non extended-release Guaifenesin products here.
My point is you have to dig down deeper than the article does to understand what is going on. The FDA is giving priority to enforcing the ban on unapproved drugs for 7 different reasons. This ends up being 7 different categories for which a single unapproved drug would only fall into one if it qualifies at all. There are a lot of different issues here covering a lot of different drugs and the article mistakenly tries use a broad stroke in painting the whole situation as just a grab for profits.

Re: Guaifenesin, another example

The guaifenesin issue predates the 2006 initiative on tightening the regulation of Unapproved Drugs. The FDA moved against guaifenesin manufacturers in 2002. Adams Labs came to the FDA and offered to do detailed testing of an existing drug, but in a new sustained release product -- Mucinex. Prior to that time, guaifenesin had been primarily sold as a generic immediate release drug. In 2002, virtually all guaifenesin, except Mucinex, disappeared from the market overnight. After a couple of years, immediate release guaifenesin reappeared in the US market, and I don't know the details surrounding the FDA's regulation of that return to market.
What I do know is that when generic guaifenesin disappeared, Mucinex was sold at about 4X the cost of the preceding generic products.

Re: Guaifenesin, another example

If I tell you that you now have to pay 100x the 'normal cost' for the 'same basic treatment' you would have no problem with this, since the 'new' formula is FDA approved?

Does it really matter what the reasons for the ban's are if there is no significant risk associated with the items being banned (if there was they would have been pulled years ago, right?)

This one is being banned because Joe Senator's son's company makes a medical version that sells for 100x the price, but still costs us 1/100th to manufacture. That one is being banned because Charlie Congressman was 'lobbied' extensively (he got a new cabin cruiser, a vacation home, and a 10 year supply so he doesn't have to pay the markup).

These reasons make just about as much sense as some of the ones the FDA is pushing (probably more if someone had the actual details.... where's wikileaks when you need them)...

nature and dna is patented too. if someone discovers something in your dna that is useful you don't own it the person or company who discovered it does... gmo seeds have to be purchased every year... you can't save the seeds from the best plants and reuse them.

Quinine Sulfate

This is really just a series of questions for the author, David Fuchs, (or someone else) to answer.
The FDA says the main problem for the unapproved quinine sulfate drugs is the labelling. It should only be used for malaria and "is known to have a very narrow margin of safety between doses that are therapeutic in the treatment of malaria and doses that are toxic".

1). Can't a drug company just make a label that is acceptable to be approved by the FDA?

2). Why would a company have to duplicate expensive clinical trials when all they should have to show is that their dosages fall into the known acceptable range and are correctly labelled?

3) How much does it cost to go through the approval process? Pharmaceutical companies have to do this to make generic drugs. How is quinine sulfate any different?

Re: Re: Quinine Sulfate

"3) Current estimates for new discovery to drug has a tally of $1.2 billion or so, counting failures."

This article is about generics that have been around for a century. You are quoting new drug discovery number and not answering his question about generics. They are apples and oranges. The $1.2 billion dollar price tag is inflation adjusted dollars from a 2003 pharmaceutical industry sponsored study, which is original $800 million dollar figure so often quoted.

Re: Re: Quinine Sulfate

"3) Current estimates for new discovery to drug has a tally of $1.2 billion or so, counting failures."

Estimates by whom, the pharma industry? and why should I believe them?

These are inflated numbers, we know that now.

Besides, the U.S. govt usually funds drug discovery up to the point where something is shown likely not to be a failure. The U.S. govt takes all the risks and after it's shown that something shows promise, then pharma takes over from there.

Re: Re: Quinine Sulfate

An generic drug overview:
I think it is a good thing to have all medicinal drugs approved by the FDA. I also think it is a good thing to require a company to pass checks on it's manufacture of a particular medicinal drug (i.e. be approved by the FDA). The general public does not want drugs to be too expensive and, in particular, generic drugs should never be expensive. Once a drug is manufactured by at least two companies, the competition should keep prices low. So, what's the problem?
The cost of entering the market has to be low enough for at least two companies to be involved. I will not consider marketing because that is a variable cost determined by a company itself. Also, if your drug is, say, 1/4 of the cost of your competitor's then it will market itself. So, the main investment cost then is getting FDA approval and this has to be balanced against the total size of the market, This gives three categories.

1) Orphan drugs: No one wants to manufacture the drug so the government must supply some artificial incentive disrupting normal market forces. We've seen an existing problem concerning that with Diulatin.

2) Popular Drugs: These are all the existing generic drugs with approval given by the FDA to multiple companies.

3). Drugs with a small potential market. This category should not exist. The cost of getting approval should never be so discouraging that a second company will never attempt it. This is what I think the focus should be on.

We can assume that drug companies are greedy and are always looking to maximize profit. I cannot fault the FDA with deciding to bring all drugs under the approval process. Sure, it disrupts the market at this late date but things will equilibrate in the long term (not too long). This assumes influence of big pharma hasn't warped the process. The government should be making sure that safety is the criteria and not profit for any approval procedures. I still can't believe the ANDA procedure is all that costly.

Re: Re: Re: Quinine Sulfate

That is getting to complex. Do not fall for the misdirection that Scotty and CarlWeathersForPres are throwing out. Scotty is trying to confuse generic drugs with the cost of new prescription drugs. CarlWeathersForPres is trying to confuse supliments with prescription drugs and throwing in fear for good measure.

Since the article is focused on generic drugs lets stick with them. Drugs (pill for this example) whether they are OTC or prescription must meet certain criteria. They must be of a certain purity (90%-110% per pill). They must disolve and have 80% of their active ingedients release in a certain amount of time. They must be packaged in a certain way to prevent degredation. The mass of active and inactive ingedients must all be within a certain ranges per pill. In other words there are standards.

Given this information what are your thoughts on the production of generic (out of patent) drugs? Who should be able to produce them? How should we check for purity and how often should we check? Should the FDA be allowed to pull drugs that meet all criteria? What should the criteria be?

Ugh

This article doesn't do fair justice to the intricacies involved in these decisions and the measures put in place by the federal government to encourage the execution of costly and risky human clinical trials by the private sector.

The word "monopoly" gets sloppily throw around by people criticizing the pharmaceutical industry, not realizing that pharma is composed of hundreds of companies in cutthroat competition with each other. The so called "monopolies" on a given drug are given, for a set time, to companies who own the patent +3-5 years of data exclusivity in exchange for running costly trials. Without these incentives, we don't get new drugs anymore.

With respect to generics companies, they too have to run trials... much less expensive ones, but trials nonetheless. The FDA is simply preventing people from selling supplements as drugs without providing data that they work the same as the approved drug. This is intended to protect patients! I'm still able to get my tonic water... but if a company was selling this tonic water as a cure for malaria, the FDA had better make sure that the tonic water actually works as well as the quinine sulfate pills. Maybe it does... maybe it doesn't, but before you sell it as a cure, you have to prove that it does. This is a very GOOD thing.

Re: Re: Ugh

and besides, the govt funds much of the R&D required to develop the drugs that pharma ends up getting patents on.

Those who claimed that this is somehow good for society did so without making any effort to investigate or reason through the issue, they simply claimed that whatever is in their best interest is in the public interest (even though they really know better). Many of those who lobby for the existence of patents under the pretext that they're in the public interest are the same liars who lobbied for privately owned govt funded patents under the pretext that they're in the public interest and since their stated opinion about privately owned govt funded patents is a lie based on no evidence with no effort to investigate/research or reason through the issue to discover the truth, it is likely that their argument that patents are beneficial to the public is made with the same lack reasoning, investigation, and supporting evidence.

Why should we trust pharmaceutical corporations to decide for us that patents are in the public interest when patents are clearly in their private interest and hence they have a conflict of interest. The decision about whether or not patents should exist should largely be made without their input (not that they can't give their input, just that the decision should mostly ignore their input) since their input is more likely to serve their personal interests over the public interest. But that's not how our system works, the way our system works is that special interests have a disproportionately large influence over these decisions when it is them that should have a disproportionately small influence due to their conflict of interest.

Now, you may argue that the public also has an interest in the matter, but that's fine, because the purpose of government should be to serve the public interest and who's to better decide whats in the public interest than the public? (not the government and certainly not pharmaceutical corporations).

Re: Re: Re: Ugh

(and the legal system that grants patents is the same legal system that grants privately owned govt funded patents, the later is proof that the legal system is corrupt which increases suspicion that the former is an act of corruption with little intent to serve the public interest. and if it's not intended to serve the public interest, it probably doesn't. 95+ year copy'right' lengths is also an act of corruption, again, highlighting how corrupt our legal system is and bringing suspicion upon the intent, and hence the effect, of other similar laws. That's partly how we know that patent and copy'right' laws likely have corrupt intentions and hence likely result in a public detriment).

Re: Re: Re: Re: Ugh

(it's like with the whole ACTA issue, why was the industry invited to these secretive meetings? Who are they to tell our government what's in the public interest? If anything, they're the exact ones that shouldn't be invited, they have a clear conflict of interest in the matter).

Re:

(and I'd like to see the FDA ban fresh air. Literally, if everyone opened their window as a decongestant, we will immediately put 99% of all cold/cough medication manufacturers completely out of business. Animals in nature don't insulate themselves in a bubble, why should we? It's unnatural and is the cause of most respiratory sickness. Your insulated house is not a self sufficient ecosystem. Things like allergens might still be a problem though, people who are sensitive might have to filter incoming air, and people who live in apartments that place trashcans close to their apartment dorm or people who live next to refineries, especially ones that release hydrogen sulfide, might also have problems).

"Drugs like Lovaza, which is nothing more than the fish oil you can get in health food stores, and lovastatin which has been in use for roughly a thousand years (800 AD) in the form of red yeast rice"

There is a term for what these pharmaceutical corporations are doing. It's called biopiracy.

and most of the studies have substantially shown that (unadulterated) red yeast rice is both safer and more effective at lowering bad cholesterol and increasing good cholesterol than pharmaceutical drugs (but, at least in the U.S., regulations restrict the concentration of the naturally occurring active ingredient to artificially reduce effectiveness. This is common practice for our tyrannically corrupt FDA).

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FDA

So what else is new? The FDA has to be the crookedest federal department ever created and takes more bribes then the GOP.

When national health care fully kicks in who is going to pay the bill for these new price inflated drugs, many that have not been inspected or even tested? Tax payers are going to foot the bill of course. The unemployed are growing in numbers and the government figures put out as propaganda do not take in the thousands that have exhausted their unemployment benefits so these millions of uninsured people will be placed on government paid insurance at tax payer expense.

Why would Obama support this crime if he was really into cheap affordable health care for all. Obama can't seem to get his pea brain out of the corporate pocket unless he's in a foreign country instructing another basketball team.

"regulation"

Government by the people "in government"
For the people "in government"
Take away the unnecessary health care for your Representatives and more importantly stop the absurd idea that any member of a regulatory organization -thats nearly all elected or appointed officials - can hold stock while in office or for a period of ten years after holding office and America would be a good place to live and work.

MEBARAL(AN ANTI-SEIZURE DRUG)has been pulled by the fda and will be eliinated by years end.Reason:it was never approved and has been used for decades.This has worked for many people.What more approval is needed???This needs to be carefully looked at and be reversed by the FDA.So many points on this site have been made,some i agree with others not.I will say this much,I shall be in touch with all who will listen.My life does not belong in the hands of $$$ makers that now run Washington.This is a safe med. and is just being looked at...give me a break!!!the American people are a bright people and this is one of the times I need to be heard....

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I totally agree. My case is not as serious but granted I will be having to go to the doctor by next week with a serious sinus infection and ear ache. Shot will not be covered by my insurance and it will be a up and down battle to try to stay well....

Re: Mebaral

why do they just want power over life? it was a great drug for over 50 years. i hear lundbeck has been allowed to put sabril on the market which guarentees 33% of it's users will go blind and they are following them. why can't they look at the old records of mebaral users and make an honest not money decision? to hear that it can pass sabril with such danger and drop mebaral makes no sense. lundbeck bought ovation just last year and then dropped the drug even though it is the sole manufacturer of an orphan drug. i would not trust them or buy any of their products unless they explain their decision.

I have been taking an allergie Medicine, Norel now for over a year. For over a year I have not been to the doctor for a shot, Not had an ear ache where my ears were so full of fluid I could hardly function. This medicine kept me well. Just one little pill at bed time. Well now for a week I have been sneezing, blowing my head off. My neck is starting to hurt today, a sign my ears of filling with fluid. I am told to try this, and this over the counter drug...well I'm getting sicker by the moment. These do not work. Our world is becoming where our government is sticking their nose into our business a little too much....get em' all out of the whitehouse...cut their pay and our budget will be balanced and we folks can decide what we can do with our health, good Lord this is so crazy.

true

however some of us were stuck with unapproved aed's being removed from the market withou generic replacements such as mebaral by lundbeck company's decision. others such as lamotringe cause aseptic menigiti. wake up fda follow tried and true in the epileptic sickness.

Patented formerly generic drugs

I am a gout sufferer, and used to get my colchicine prescription for 3 dollars for a 60 day supply. Pharma, the drug company that has been given the patent now for colchicine is now selling it for 161 dollars per 30 days supply. This is driving many of us out of the market. I have insurance, but it now classifies it as a NAME BRAND PATENTED DRUG, instead of a generic, which means my copay is now 66 dollars, instead of the 11 for a generic. This is an insult to Americans who are barely surviving! My research shows the only testing Pharma did on the drug to get FDA approval was a 5000 dollar survey which asked gout sufferers if they got relief from the drug! I can find nothing else! Perhaps it exists but in this day of computer searches, it should not be hard to find and I cannot. The country needs to know someone has profited off the misery of others and it serves NO decent purpose! They have not even changed the chemical make up of the drug nor its dosage,it is identical the same makeup as I have been using for 30 plus years! .06 mg per dose.